Cenerimod for Systemic Lupus Erythematosus
(OPUS-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing cenerimod, a medication aimed at reducing symptoms of Systemic Lupus Erythematosus (SLE) in adults with moderate to severe symptoms. Researchers want to see if cenerimod can help when added to existing treatments. The medication works by calming the overactive immune system, which may reduce inflammation and other symptoms.
Will I have to stop taking my current medications?
The trial does not require you to stop your current medications for Systemic Lupus Erythematosus, as it tests cenerimod on top of existing treatments. However, your current medications must be stable for a certain period before joining the trial.
Is Cenerimod safe for humans?
Cenerimod has been tested in healthy subjects and was found to be safe and well-tolerated, with only one minor adverse event (eye irritation) that was not linked to the drug. It caused a temporary decrease in heart rate, which is common with similar drugs, but no serious safety concerns were reported.12345
How does the drug cenerimod differ from other treatments for systemic lupus erythematosus?
Cenerimod is unique because it is a selective sphingosine-1-phosphate 1 receptor modulator, which works by affecting the immune system to reduce inflammation, and it is taken orally. This mechanism of action is different from many other treatments for systemic lupus erythematosus, which often involve suppressing the immune system more broadly.35678
What data supports the effectiveness of the drug Cenerimod for treating systemic lupus erythematosus?
Cenerimod, a drug being tested for systemic lupus erythematosus, has shown similar effects in reducing lymphocyte counts (a type of white blood cell) in both white and Asian subjects, which is a positive sign for its potential effectiveness. Additionally, it was well-tolerated with minimal side effects, suggesting it could be a safe option for patients.345910
Who Is on the Research Team?
Clinical Trials
Principal Investigator
Idorsia Pharmaceuticals Ltd.
Are You a Good Fit for This Trial?
Adults with moderate to severe Systemic Lupus Erythematosus (SLE) who have been diagnosed at least 6 months prior and are on stable SLE medications can join. They need a certain level of disease activity and organ involvement, and women must agree to pregnancy tests and use effective contraception. Excluded are those with heart rate issues, certain heart conditions, severe respiratory diseases, liver problems, recent serious cardiovascular events or treatments that could interfere.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cenerimod or placebo once daily in addition to background SLE therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cenerimod
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Idorsia Pharmaceuticals Ltd.
Lead Sponsor
Antonio Olivieri
Idorsia Pharmaceuticals Ltd.
Chief Medical Officer since 2024
Not specified
André C. Muller
Idorsia Pharmaceuticals Ltd.
Chief Executive Officer
Not specified